Status:
COMPLETED
Management With Accupril Post Bypass Graft
Lead Sponsor:
Montreal Heart Institute
Collaborating Sponsors:
Pfizer
Conditions:
CABG
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Angiotensin converting enzyme (ACE) inhibitors have been shown to improve survival and to reduce the risk of cardiovascular events in some groups of patients following myocardial infarction. This stud...
Detailed Description
The IMAGINE study is a double-blind, placebo controlled, parallel group, randomized, multi-centre international study conducted in patients who have undergone CABG. The research protocol was approved ...
Eligibility Criteria
Inclusion
- Post-CABG less than or equal to 7 days (10 days in France)
- Stable post-operation (as per investigator judgement)
- Still in hospital
- 18 years of age or older
- LVEF ≥40 percent determined within six months before surgery
Exclusion
- Intolerance/contraindication to ACE-inhibitor or history of angioedema
- Insulin-dependent diabetes, or type II diabetes with microalbuminuria
- Clinical need for an ACE inhibitor or an angiotensin receptor blocker (investigators' judgement)
- Current need for post-CABG urgent intervention
- Valve replacement, not repair, during index CABG
- Significant valve stenosis or cardiomyopathy
- Serum potassium concentration of 5.6 mmol per liter or more
- Primary hyperaldosteronism
- Serum creatinine greater than 2.26 mg per decilitre (suspected renal artery stenosis, single kidney or renal transplant
- Serious concomitant disease, such as cancer, AIDS, sepsis
- SBP \>160 mm Hg or DBP \<90 mm Hg despite treatment
- SBP \<100 mm Hg
- Significant peri-operative myocardial infarction
- Pregnancy, breastfeeding, inadequate contraception
- Investigational drug use \<30 days
- Drug, alcohol abuse, inability to adhere to protocol.
Key Trial Info
Start Date :
November 1 1999
Trial Type :
INTERVENTIONAL
End Date :
May 1 2005
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00269243
Start Date
November 1 1999
End Date
May 1 2005
Last Update
February 8 2006
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